Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults

NCT05428228 | Recruiting

• 1 other identifier: SOW6
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the clinical trial is to evaluate the efficacy of two novel hydration products on rehydration following exercise.

Conditions

Dehydration; Rehydration; Exercise Performance; Exercise Recovery; Cognitive Performance

Outcome Measures

Primary Outcomes (1)

• Relative rehydration

  To determine the effect of the test products (TPs) on relative rehydration after exercise, as compared to placebo via percent plasma volume change and plasma osmolality

  Through study completion, an average of 8 weeks

Secondary Outcomes (2)

• Hydration status via sweat loss

  Through study completion, an average of 8 weeks

• Participants reported outcomes

  Through study completion, an average of 8 weeks

Other Outcomes (2)

• Relative effects of dehydration and rehydration

  Through study completion, an average of 8 weeks

• Exercise performance

  Through study completion, an average of 8 weeks

Study Arms (3)

TP1

EXPERIMENTAL

Participants will be administered TP1 during one of the experimental visits.

Other: TP1

TP2

EXPERIMENTAL

Participants will be administered TP2 during one of the experimental visits.

Other: TP2

Placebo

PLACEBO COMPARATOR

Participants will be administered placebo during one of the experimental visits.

Other: Placebo

Interventions

TP1 OTHER

Participants will be administered TP1 during one of the experimental visits.

TP1

TP2 OTHER

Participants will be administered TP2 during one of the experimental visits.

TP2

Placebo OTHER

Participants will be administered placebo during one of the experimental visits.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male and female participants who are between 18 and 49 years of age (inclusive). Are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit. Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive). Exercise regularly as per physical activity guidelines for Americans \[structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)\] and willing to maintain the same level of physical activity throughout the study period. Can maintain their exercise status at the beginning of the study throughout the study period. Can achieve a peak VO2 at screening that is at least 60% of their age and gender matched normative value per American College of Sports Medicine recommendations. Have normal or acceptable to the investigator vital signs (BP and HR) at screening. Individuals with childbearing potential: Agree to have urine pregnancy test performed on each trial day. Able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read the questionnaires, and carry out all study-related procedures.

You may not qualify if:

• Female participants who are lactating, pregnant or planning to become pregnant during the study. Carry a diagnosis of diabetes. Weigh less than or equal to 80 pounds at any visits. Answer "yes" to any of the questions asked on the screening questionnaire (Appendix 10.2.1). Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit). Use any dietary supplements that may impact hydration status within the 30 days prior to the baseline visit (Familiarization Trial/Visit 2). Participants must observe a 30-day washout period of no supplementation to be eligible. Consume more than two standard alcoholic drinks per day. Use of inhalables, smokables, or the like (e.g., cigarettes, vaporizers, water pipes, or cannabis) within 30 days prior to the first dose of the study product or for the duration of the study. Have a medical condition that may impact ability to exercise or ability to ingest prescribed fluid volume. Smoking tobacco products.

Sponsors & Collaborators

• Liquid I.V.: lead
• University of Memphis: collaborator

Study Sites (1)

The University of Memphis

Memphis, Tennessee, 38152, United States

RECRUITING

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Bloomer, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Lelko, MS

CONTACT

6787934226; michael.lelko@liquid-iv.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 23, 2022
• Study Start: October 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)